NCT01334216

Brief Summary

The CHICA system is a clinical decision support system that uses adaptive turnaround documents to provide point-of-care information to clinicians. The investigators will be studying whether it can help to support parents in their efforts to quit smoking.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
362

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 13, 2011

Completed
5.9 years until next milestone

Results Posted

Study results publicly available

March 14, 2017

Completed
Last Updated

September 13, 2017

Status Verified

August 1, 2017

Enrollment Period

1.9 years

First QC Date

April 11, 2011

Results QC Date

January 24, 2017

Last Update Submit

August 15, 2017

Conditions

Cigarette Smoking

Keywords

smokingquittingtobaccoParental

Outcome Measures

Primary Outcomes (1)

  • Parental Smoking Quit Rate

    This is the number of participants who quit smoking

    one year

Study Arms (2)

CHICA Smoking Cessation Module

ACTIVE COMPARATOR

This arm had the CHICA smoking cessation module turned on

Other: CHICA Smoking Cessation Module

CHICA Placebo

PLACEBO COMPARATOR

This arm had CHICA without the smoking cessation module

Other: CHICA Placebo

Interventions

CHICA Smoking Cessation ModuleOTHER

The CHICA module helped to screen parents for smoking and assist them in quitting.

CHICA Smoking Cessation Module
CHICA PlaceboOTHER

This was CHICA without the study module.

CHICA Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parent of child in our clinics who reported cigarette smoking

You may not qualify if:

  • Not smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Health Services Research

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Cigarette SmokingSmoking

Condition Hierarchy (Ancestors)

Tobacco SmokingBehaviorTobacco Use

Results Point of Contact

Title
Stephen M. Downs, MD, MS
Organization
Indiana University School of Medicine
stmdowns@iu.edu
3172780552

Study Officials

  • Stephen M Downs, MD, MS

    Indiana University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 11, 2011

First Posted

April 13, 2011

Study Start

July 1, 2008

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

September 13, 2017

Results First Posted

March 14, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)